APPLICATION
ANDA075150
TYPE
ANDA
ORIGINAL APPROVAL
1998-10-05
LATEST ACTION
2012-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLONAZEPAMPrescription
CLONAZEPAM 1MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 2MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.5MG · TABLET · ORAL
Approval history
2012-10-25Labeling · Supplement 15 · standardAP
2011-04-08Labeling · Supplement 13AP
2009-10-15Labeling · Supplement 11AP
2003-11-24Labeling · Supplement 3AP
2001-02-28Labeling · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.